This is a 28-day clinical trial studying the safety of the house dust mite tablet in adolescents with allergic rhinitis/rhinoconjunctivitis. The purpose of this trial is to collect additional safety information about a tablet used to treat house dust mite allergies, when used to treat adolescents who have these allergies. The trial medication used is already approved to treat allergic rhinitis caused by house dust mite in adults and adolescents (12-17 years old) in several countries.
This trial is a 28-day, single-arm open-label phase III trial to evaluate safety of the house dust mite SLIT-tablet in adolescents (12-17 years of age) with HDM allergic rhinitis/rhinoconjunctivitis with or without asthma. Approximately 250 adolescents will be enrolled in the trial and will receive the house dust mite SLIT tablet. The trial is conducted in several European countries.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
253
Sublingual allergy immunotherapy tablet, for daily administration (1 tablet per day)
Number of Subjects With at Least One Treatment-emergent Adverse Event (TEAE)
At least one TEAE
Time frame: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.
Proportion of Subjects With at Least One Treatment-emergent Adverse Event (TEAE)
At least one TEAE
Time frame: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.
Number of Treatment-emergent Adverse Events (TEAEs)
At least one TEAE
Time frame: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.
Number of Subjects With at Least One Solicited Treatment-emergent Adverse Event (TEAE)
At least one solicited TEAE
Time frame: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.
Proportion of Subjects With at Least One Solicited Treatment-emergent Adverse Event (TEAE)
At least one solicited TEAE
Time frame: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.
Number of Solicited Treatment-emergent Adverse Events (TEAEs)
At least one solicited TEAE
Time frame: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.
Number of Subjects With at Least One IMP-related Adverse Event (AE)
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At least one IMP-related AE
Time frame: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.
Proportion of Subjects With at Least One IMP-related Adverse Event (AE)
At least one IMP-related AE
Time frame: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.
Number of IMP-related Adverse Events (AEs)
At least one IMP-related AE
Time frame: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.
Number of Subjects With At Least One Treatment-emergent Serious Adverse Event (SAE)
At least one treatment-emergent SAE
Time frame: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.
Proportion of Subjects With At Least One Treatment-emergent Serious Adverse Event (SAE)
At least one treatment-emergent SAE
Time frame: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.
Number of Treatment-emergent Serious Adverse Events (SAEs)
At least one treatment-emergent SAE
Time frame: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.